Guidance for Industry -Statistical Approaches to establishing bioequivalence, 2001. ,
Note for guidance on the investigation of bioavailability and bioequivalence, 2001. ,
Pharmacokinetic and pharmacodynamic data analysis: concepts and applications, 2006. ,
Nonlinear assessment of phenytoin bioavailability, Journal of Pharmacokinetics and Biopharmaceutics, vol.61, issue.4, pp.327-336, 1976. ,
DOI : 10.1007/BF01063122
Estimation of rhG-CSF absorption kinetics after subcutaneous administration using a modified Wagner???Nelson method with a nonlinear elimination model, European Journal of Pharmaceutical Sciences, vol.13, issue.2, pp.151-158, 2001. ,
DOI : 10.1016/S0928-0987(00)00219-0
The Utility of the Population Approach Applied to Bioequivalence in Patients, Therapeutic Drug Monitoring, vol.27, issue.5, pp.592-600, 2005. ,
DOI : 10.1097/01.ftd.0000174005.51383.2f
Evaluation by simulation of tests based on non-linear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over trials, Statistics in Medicine, vol.83, issue.10, pp.1509-1524, 2005. ,
DOI : 10.1002/sim.2047
Nonlinear Mixed Effects Models for Repeated Measures Data, Biometrics, vol.46, issue.3, pp.673-687, 1990. ,
DOI : 10.2307/2532087
Mixed-effects models in S and Splus, 2000. ,
Convergence of a stochastic approximation version of EM algorithm. The Annals of Statistics, pp.94-128, 1999. ,
Coupling a stochastic approximation version of EM with an MCMC procedure, ESAIM: Probability and Statistics, vol.8, pp.115-131, 2004. ,
DOI : 10.1051/ps:2004007
The SAEM algorithm for group comparison 27 Design and analysis of bioavailability and bioequivalence studies ,
Linear Mixed Models for Longitudinal Data, 2001. ,
DOI : 10.1007/978-1-4612-2294-1_3
Applied mixed models in medicine -second edition, 2006. ,
Bioequivalence trials, intersection-union tests and equivalence confidence sets, Statistical Science, vol.11, pp.283-319, 1996. ,
Bias of two one-sided tests procedures in assessment of bioequivalence, Statistics in Medicine, vol.40, issue.8, pp.853-861, 1995. ,
DOI : 10.1002/sim.4780140813
Shrinkage in empirical Bayes estimates for diagnostics and estimation, 2007. ,
A note on the delta method. The American Statistician, pp.27-29, 1992. ,
A comparison of estimation methods in nonlinear mixed effects models using a blind analysis, 2005. ,
A survey of population analysis methods and software for complex pharmacokinetic and pharmacodynamic models with examples, The AAPS Journal, vol.9, issue.1, pp.60-83, 2007. ,
DOI : 10.1208/aapsj0901007
Bioequivalent or nonbioequivalent ? Pharmalogical Research, pp.543-546, 2001. ,
Pharmacogenetics and population pharmacokinetics: impact of the design on three tests using the SAEM algorithm, Journal of Pharmacokinetics and Pharmacodynamics, vol.30, issue.4, pp.317-339, 2009. ,
DOI : 10.1007/s10928-009-9124-x
URL : https://hal.archives-ouvertes.fr/inserm-00406739
An unbiased test for the bioequivalence problem. The Annals of Statistics, pp.2345-2367, 1997. ,
A Simple Numerical Approach Towards Improving the Two One-Sided Test for Average Bioequivalence, Biometrical Journal, vol.19, issue.2, pp.205-211, 2008. ,
DOI : 10.1002/bimj.200710407
Extension of the SAEM algorithm for nonlinear mixed models with 2 levels of random effects, Biostatistics, vol.10, issue.1, pp.121-135, 2009. ,
DOI : 10.1093/biostatistics/kxn020
URL : https://hal.archives-ouvertes.fr/inserm-00383201